Serious sling complications may be under-reported

November 16, 2015

A recent systematic review found that the total incidence of serious complications and/or sling failure with respect to incontinence was 15.3%.

Montreal-Serious complications associated with implantation of synthetic midurethral sling (SMUS) surgery may be under-reported in the peer-reviewed literature and serious adverse outcomes and surgical failures are on the order of 15.3%, according to findings from a systematic review presented at the International Continence Society annual meeting in Montreal.

"There appears to be a pretty high complication rate (of SMUS surgery),” said lead author Jerry Blaivas MD, of Weill-Cornell Medical School, New York, and State University of New York Downstate Medical School, Brooklyn. “There is a subset of patients who suffer severe, lifestyle-altering complications in whom a satisfactory outcome is never achieved despite multiple correct surgeries. These unfortunate patients have recently been described as 'changed women,’ " (Female Pelvic Med Reconstr Surg 2014; 20:131-6).

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Despite these concerns, SMUS surgery has gained wide appeal because it can be completed quickly and has minimal short-term morbidity when these serious complications do not occur, noted Dr. Blaivas.

Dr. Blaivas and co-investigators conducted a search of the English-language literature in 2014 to assess complications linked to SMUS surgery, including articles from 2007 onwards. They defined serious complications as those that necessitated more surgery such as urethral obstruction, vaginal, bladder, and urethral erosion, urinary fistulas, bowel injury, and serious infections. They also defined serious complications as those that were refractory to treatment and were lifestyle altering such as chronic pain, de novo overactive bladder, and recurrent or persistent stress urinary incontinence (SUI).

Next: 337 records included for review

 

The incidence of complications was arrived at by dividing the total number of patients with specific complications by the total number of patients reported in the peer-reviewed literature, including single case reports and case series of complications, explained Dr. Blaivas. A total of 995 records were initially retrieved and 746 were excluded because of a lack of relevance, leaving 249, but another 88 records were included after reviewing references from reviewed papers, with 337 representing the basis for the review.

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They calculated a 3.2% incidence of urethral obstruction, a 2% incidence of erosion/extrosion/exposure, a 0.3% incidence of fistulas, and a 0.1% incidence of bowel injury or infection. The lifestyle-altering complications such as chronic pain, refractory and de novo OAB, and recurrent/persistent SUI had incidences of 4.3%, 3.9%, and 5.3%, respectively. The total incidence of serious complications and/or sling failure with respect to incontinence was 15.3%.

A review of the Maude database confirmed at least 28 postoperative deaths after SMUS, yet the investigators found only a single case report of a postoperative death in the literature.

Next: "The overall quality of the studies included in the review was particularly poor with respect to complications."

 

"The overall quality of the studies included in the review was particularly poor with respect to complications. Further, the vast majority had follow-up periods of less than 2 years, while complications have been reported more than 10 years after the original surgery," Dr. Blaivas said.

"The complication rate (of SMUS surgery) is not so low, and we believe that complications are under-reported," said Dr. Blaivas. "Physicians should counsel their patients that complications could happen to them. It is not enough to tell patients that sling surgery is safe and effective. They should be informed of the risks (of complications) in terms of the numbers and percentages and let the patient decide for herself what is safe."

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